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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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MIGLUSTAT

All products: not a benefit

Other products in the same Health Canada class (A16A, A16AX) — coverage varies; not interchangeable

  • Sapropterin (Kuvan): not a benefit
  • Levocarnitine (Carnitor): not a benefit

Sandoz Miglustat · DIN 02456257 · 100mg · capsule

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Sandoz Miglustat · DIN 02456257 Manufacturer: Sandoz Canada Inc.; listing date 2020-06-30 Health Canada: Marketed since 2020-04-20 · brand SANDOZ MIGLUSTAT · ATC A16AX06 MIGLUSTAT · form Capsule · route Oral · ingredients MIGLUSTAT 100 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Miglustat: Formulary list price $81.4125/unit (unit not stated in source; not the patient's cost)

Ministry pays: $81.4125 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94314 · Verify on the e-Formulary ↗ (DIN 02456257)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02456257). DIN 02456257: Sandoz Miglustat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000559; group id 934; item number 2228; lccId None; manufacturer id SDZ Source form: Cap; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $81.4125; ministry $81.4125 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02456257 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94314
Interchangeable products
Zavesca · DIN 02250519 · $81.4125
Shortage status: resolved shortage (ended 2025-05-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02456257
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

SAPROPTERIN DIHYDROCHLORIDE

· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg, 500mg · Pd for Sol (Sachet Pk)

LEVOCARNITINE

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg/mL · Oral Sol (with preservative)

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS ZAVESCA® (miglustat) is indicated for:  the treatment of adult patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.  slowing the progression of some of the neurological manifestations in adult and pediatric (4- 17 years of age) patients with Niemann-Pick Type C disease. 1.1 Pediatrics There is no experience with the use of ZAVESCA ® in patients with type 1 Gaucher disease under the age of 18; therefore, Health Canada has not authorized this indication for pediatric use. Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ZAVESCA® in pediatric patients aged 4 to 18 years with Niemann-Pick Type C disease has been established. However, patients below 4 years of age were not enrolled in the prospective study of ZAVESCA® in Niemann-Pick Type C disease. Therefore, Health Canada has authorized this indication for use in pediatric patients aged 4 to 18 only. 1.2 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. https://pdf.hres.ca/dpd_pm/00064388.PDF PM date: January 17, 2022 Source product: ZAVESCA; DIN 02250519; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Sandoz Miglustat: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026